FDA 510(k)

Q 脉冲激光机

K号: K193609 · 2020-03-20

决定日期2020-03-20

产品代码GEX

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决定实质等同

器械摘要

Q Switched Nd: YAG Laser machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193609. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Q Switched Nd: YAG Laser machine?

Q Switched Nd: YAG Laser machine is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. The 510(k) number is K193609.

When did Q Switched Nd: YAG Laser machine receive FDA 510(k) clearance?

Q Switched Nd: YAG Laser machine received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193609.

Who is the listed applicant for Q Switched Nd: YAG Laser machine?

The FDA 510(k) record lists Beijing Lead Beauty S & T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Switched Nd: YAG Laser machine?

The FDA product code for Q Switched Nd: YAG Laser machine is GEX. This falls under the Gastroenterology category.

列明Beijing Lead Beauty S & T Co., Ltd.为申报人的其他记录

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K192735二极管激光脱毛机

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